The Insemination Kit is a complete system for the simple and safe preparation and processing of human spermatozoa out of the ejaculate for homologous and hetereologous intrauterine inseminations (IUI).
The Insemination Kit uses the self motility of the male germ cells to isolate motile spermatozoa in high concentrations. We recommend the use if the ejaculate is normozoospermic and slightly oligo- and/ or asthenozoospermic.
|Insemination Kit||FGY4SA-Kit-002||complete system for one Insemination|
Product facts and notices
- NaCl, KCI, KH2PO4, MgSO4.7H2O, NaHCO3, CaCl2.2H2O, D(+)-Glucose anhydrous, Na-Lactate (50 % solution), Na-Pyruvate, EDTA, Alanyl-Glutamine, 21 mM HEPES, water, non-essential and essential Amino Acids, human serum albumin (5.00 g/Liter), Gentamicin (10 mg/Liter), Phenolred.
Product specifications and quality control
- All raw materials are of highest available purity (European Pharmacopoeia and/or USP standard) if applicable.
- A certificate of analysis is available for each batch upon request from our website with respective lot number.
- The MSDS for GM501 SpermAir is available upon request and can also be downloaded from our website.
- GM501 SpermAir is manufactured according to the following specifications:
|pH (at 37°C)||7.20 – 7.40|
|Sterility||sterile – SAL 10-3 (Sterility Assurance Level)|
|Endotoxins (EU/ml)||< 0.25|
|MEA (Blastocysts in %; after 5 days of culture in the product covered by mineral oil, starting from zygote stage)||
Precautions and warnings:
- GM501 SpermAir contains the antibiotic Gentamicin Sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
- Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective
manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot totally be excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of proven virus transmissions with albumin, manufactured to European Pharmacopoeia specifications by established processes.
- Therefore, handle all specimens as if capable of transmitting HIV or hepatitis. Always wear protective clothing when handling specimens.
- Always work under strict hygienic conditions (ISO 5 environment, e.g. LAF-bench) to avoid possible contamination, even when GM501 SpermAir medium contains Gentamicin.
- Only for the intended use.
- Do not use the product if bottle, seal of the container or package is opened or defect when the product is delivered.
- Do not use the product if it becomes discoloured, cloudy or shows any evidence of microbial contamination.
- The products must be dispose like potential contaminated, specific to each country.